Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

N/ACompletedNCT04155541

Pfizer40 enrolled

Overview

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Study Type

OBSERVATIONAL

Enrollment

Conditions

EGFR Mutation-positive Inoperable or Reccrent NSCLC

Interventions

dacomitinib hydrateDRUG

The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate) Exclusion Criteria: * Exclusion criteria is not provided in this study

Locations (1)

Pfizer Japan

Tokyo, Japan

Outcomes

Primary Outcomes

The Number and Percentage of Participants With Interstitial Lung Disease (ILD)

An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis.

Time frame: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).

Secondary Outcomes

Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1"

The response rate was calculated based on the best overall response as evaluated by the physician in accordance with the RECIST - Revised Version 1.1. The response rate was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR). In addition, the response rate and its two-sided 95% confidence interval (using exact method) were calculated. The participants not reported response were considered to have achieved a best overall response other than CR or PR.

Time frame: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.

Data from ClinicalTrials.gov

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